Respiratory FailureREVIVERNCT05855213
HVNI for Successful Weaning in Respiratory Failure
A study testing High Velocity Nasal Insufflation and Non-invasive positive pressure ventilation in people with Respiratory Failure and Weaning Failure, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (HVNI) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (NIPPV) as regards to weaning success rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Weaning Failure
- What is being tested?
- High Velocity Nasal Insufflation and Non-invasive positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk of extubation failure (one or more of the following):
- Age >65 years old
- BMI >30
- APACHE II score at extubation >12
- ≥2 comorbidities
- Endotracheal intubation > 7 days
Show all 10Show fewer
- ≥1 failed attempts at disconnection from mechanical ventilation
- Chronic lung disease e.g., COPD, OHS, etc.
- Underlying left ventricular dysfunction
- Non-minimal airway secretions
Who cannot join
- Non-respiratory failure patients
- Patients judged to need a tracheostomy (poor airway reflexes or copious secretions)
- Patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum)
- Patients with increased risk of aspiration, agitation, or uncooperativeness
- End stage disease with life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Chest Diseases Department, Alexandria University Faculty of Medicine
Alexandria
Ahmed S Sadaka, PhD, 00201005433152, ahmad.sadaka@alexmed.edu.eg
About this study
Official title: RolE of High Velocity Nasal Insufflation in imrpoVing wEaning Success in Respiratory Failure Patients (REVIVER)
The goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (HVNI) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (NIPPV) as regards to weaning success rate. The study will recruit those who have been on invasive mechanical ventilation for at least 3 days and with a high risk of weaning failure.
Read the detailed description
This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). After at least 72 hours from intubation, for respiratoy failure, those who are considered to be eligible for weaning from mechanical ventilation based on the weaning protocol but are at high risk for extubation failure will be randomized to either HVNI or NIPPV. Data on the respiratory and cardiovascular status will be continuously monitored and recorded thereafter.
The primary outcome measure will be failure of either arm within 72 hours of initiation, leading to reintubation (or crossover only from a failed HVNI allocation to NIV based on clinical judgement to avoid reintubation in selected cases). Secondary outcomes to be investigated include: 1) Failure of HVNI or NIPPV after 72 hours from initiation, 2) hospital mortality, 3) length of ICU stay, 4) length of hospital stay, 5) incidence of ventilator associated pneumonia, 6) patient tolerance and comfort, and 7) ICU readmission or mortality at 28-days post hospital discharge.
- Conditions
- Respiratory Failure, Weaning Failure
- Being tested
- High Velocity Nasal Insufflation, Non-invasive positive pressure ventilation
- Keywords
- HVNI, non-invasive ventilation, weaning failure, extubation, respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Velocity Nasal InsufflationDevice
Also called HVNI
A relatively new respiratory support modality which delivers very high velocity flows. This improves ventilatory efficiency via washing out carbon dioxide occupying the anatomical dead space of the upper airways.
Non-invasive positive pressure ventilationDevice
Also called NIPPV
An established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure.
| Study group | Role | What they receive |
|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Experimental | HVNI (Precision Flow; Vapotherm®, Inc, Exeter, NH) will be delivered using a small-bore nasal cannula initiated at a flow rate set to 35 L/min, temperature of 35-37°C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature will be titrated to optimize patient's comfort.
The target parameters after initiation will be as follows:
1. RR< 25 bpm
2. HR< 120 bpm
3. SpO2 92-94% Receives: Device: High Velocity Nasal Insufflation |
| Non-invasive positive pressure ventilation (NIPPV) | Active comparator | NIPPV will be initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at IPAP 10-20 cm H2O and EPAP 5-7 cm H2O to be titrated according to patient's response and comfort. FiO2 will be initiated at 1.0 for noninvasive positive-pressure ventilation.
The target parameters after initiation will be as follows:
1. RR< 25 bpm
2. HR< 120 bpm
3. SpO2 92-94% Receives: Device: Non-invasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of HVNI / NIPPV within 72 hours of initiation
need to withdraw allocated respiratory support modality based on predefined arm failure criteria
Measured: within 72 hours from start of either allocated modality
Secondary outcomes (7)
Failure of HVNI / NIPPV after 72 hours of initiation
need to withdraw allocated respiratory support modality based on predefined arm failure criteria
Measured: beyond 72 hours from start of either allocated modality
Length of ICU stay
number of days from ICU admission to discharge
Measured: Through study completion, an average of 1 year
Length of Hospital stay
number of days from hospital admission to discharge
Measured: Through study completion, an average of 1 year
Hospital Mortality
mortality rate in each allocated arm
Measured: Through study completion, an average of 1 year
Patient tolerance and comfort
Rate of tolerance to allocated respiratoy support modality in each arm
Measured: within 72 hours from start of either allocated modality
Incidence of ventilator associated pneumonia (VAP)
percentage of participants developing VAP
Measured: beyond 48 hours from start of invasive mechanical ventilation
ICU readmission or mortality post hospital discharge
percentage of participants from each arm needing ICU readmission or dying within 4 weeks of hospital discharge
Measured: 28 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Apr 2023
- Primary completionMar 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). Allocation arm failure , assessed after 72 hours of extubation, will be the primary outcome. Cross-over from HVNI to NIPPV may be allowed in case of HVNI failure and potential benefit as judged by the treating clinical team prior to reintubation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salama Sadaka, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855213
- Sponsor's protocol ID
- 010594
- Acronym
- REVIVER
- Status last verified
- May 2023
- First submitted
- 8 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RolE of High Velocity Nasal Insufflation in imrpoVing wEaning Success in Respiratory Failure Patients (REVIVER)
- ClinicalTrials.gov ID
- NCT05855213
- Acronym / sponsor ID
- REVIVER / 010594
- Conditions
- Respiratory Failure, Weaning Failure
- Keywords
- HVNI, non-invasive ventilation, weaning failure, extubation, respiratory failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (HVNI) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (NIPPV) as regards to weaning success rate. The study will recruit those who have been on invasive mechanical ventilation for at least 3 days and with a high risk of weaning failure.
Detailed description
This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). After at least 72 hours from intubation, for respiratoy failure, those who are considered to be eligible for weaning from mechanical ventilation based on the weaning protocol but are at high risk for extubation failure will be randomized to either HVNI or NIPPV. Data on the respiratory and cardiovascular status will be continuously monitored and recorded thereafter.
The primary outcome measure will be failure of either arm within 72 hours of initiation, leading to reintubation (or crossover only from a failed HVNI allocation to NIV based on clinical judgement to avoid reintubation in selected cases). Secondary outcomes to be investigated include: 1) Failure of HVNI or NIPPV after 72 hours from initiation, 2) hospital mortality, 3) length of ICU stay, 4) length of hospital stay, 5) incidence of ventilator associated pneumonia, 6) patient tolerance and comfort, and 7) ICU readmission or mortality at 28-days post hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). Allocation arm failure , assessed after 72 hours of extubation, will be the primary outcome. Cross-over from HVNI to NIPPV may be allowed in case of HVNI failure and potential benefit as judged by the treating clinical team prior to reintubation.
| Arm | Type | Receives |
|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Experimental | Device: High Velocity Nasal InsufflationHVNI (Precision Flow; Vapotherm®, Inc, Exeter, NH) will be delivered using a small-bore nasal cannula initiated at a flow rate set to 35 L/min, temperature of 35-37°C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature will be titrated to optimize patient's comfort. The target parameters after initiation will be as follows: 1. RR< 25 bpm 2. HR< 120 bpm 3. SpO2 92-94% |
| Non-invasive positive pressure ventilation (NIPPV) | Active comparator | Device: Non-invasive positive pressure ventilationNIPPV will be initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at IPAP 10-20 cm H2O and EPAP 5-7 cm H2O to be titrated according to patient's response and comfort. FiO2 will be initiated at 1.0 for noninvasive positive-pressure ventilation. The target parameters after initiation will be as follows: 1. RR< 25 bpm 2. HR< 120 bpm 3. SpO2 92-94% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >65 years old
- BMI >30
- APACHE II score at extubation >12
- ≥2 comorbidities
- Endotracheal intubation > 7 days
Key exclusion criteria (5 listed)
- Non-respiratory failure patients
- Patients judged to need a tracheostomy (poor airway reflexes or copious secretions)
- Patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum)
- Patients with increased risk of aspiration, agitation, or uncooperativeness
- End stage disease with life expectancy less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Velocity Nasal InsufflationAlso: HVNIA relatively new respiratory support modality which delivers very high velocity flows. This improves ventilatory efficiency via washing out carbon dioxide occupying the anatomical dead space of the upper airways. | Device | High Velocity Nasal Insufflation (HVNI) |
| Non-invasive positive pressure ventilationAlso: NIPPVAn established non-invasive ventilation method via delivery of an expiratory positive airway pressure and inspiratory positive airway pressure. | Device | Non-invasive positive pressure ventilation (NIPPV) |
Primary outcome
Failure of HVNI / NIPPV within 72 hours of initiation
Time frame: within 72 hours from start of either allocated modality
need to withdraw allocated respiratory support modality based on predefined arm failure criteria
7 secondary outcomes
Failure of HVNI / NIPPV after 72 hours of initiation
Time frame: beyond 72 hours from start of either allocated modality
Length of ICU stay
Time frame: Through study completion, an average of 1 year
Length of Hospital stay
Time frame: Through study completion, an average of 1 year
Hospital Mortality
Time frame: Through study completion, an average of 1 year
Patient tolerance and comfort
Time frame: within 72 hours from start of either allocated modality
Incidence of ventilator associated pneumonia (VAP)
Time frame: beyond 48 hours from start of invasive mechanical ventilation
ICU readmission or mortality post hospital discharge
Time frame: 28 days after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chest Diseases Department, Alexandria University Faculty of Medicine
Alexandria, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Velocity Nasal Insufflation and Non-invasive positive pressure ventilation in people with Respiratory Failure and Weaning Failure, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of HVNI / NIPPV within 72 hours of initiation (time frame: within 72 hours from start of either allocated modality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.